Clinical Trial of a Computer-driven Weaning System for Patients Requiring Mechanical Ventilation

Boston Medical Center (BMC)

Status: Terminated

Conditions: Respiratory Insufficiency

Treatments: Behavioral: Standard of Care weaning; Device: Computer-assisted weaning program

Study type: Interventional

Funder types: Other

Identifiers

NCT00606554

H-26906

Details and patient eligibility

About

The purpose of this study is to compare the efficacy of a computer-assisted ventilator weaning system (Drager Smartcare) to our current standard of care in the medical intensive care unit.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age greater than 18 years
• Initiated on mechanical ventilation via endotracheal tube
• Admitted to Medical Intensive Care Unit and Medical Intensive Care Unit Team (Harrison Avenue Campus, Menino Pavilion)
• Requiring mechanical ventilation for more than 48 hours
• Meets prespecified weaning criteria

Exclusion criteria

• Do Not Resuscitate/Do Not Intubate order
• Pregnancy
• Mechanical ventilation initiated at another hospital
• Cardiac arrest for more than 5 minutes with poor neurologic prognosis
• Tracheostomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Computer-assisted weaning

Experimental group

Description:

Group assigned to the computer-assisted weaning program

Treatment:

Device: Computer-assisted weaning program

Standard of care weaning

Active Comparator group

Description:

Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.

Treatment:

Behavioral: Standard of Care weaning